Coherent single layer high strength synthetic polymer composites for prosthetic valves

Abstract

Thin, biocompatible, high-strength, composite materials are disclosed that are suitable for use in a prosthetic valve for regulating blood flow direction. In one aspect, the leaflet material maintains flexibility in high-cycle flexural applications, making it particularly applicable to high-flex implants such as a prosthetic heart valve leaflet. The leaflet material includes a coherent single layer and an elastomer, wherein the elastomer is present in the pores of the porous coherent single layer.

What is claimed is: 
     
         1 . A prosthetic valve comprising:
 a frame; and   a leaflet coupled to the frame and movable between open and closed positions, the leaflet comprising at least one coherent single layer comprising an elastomer or elastomeric material and a synthetic polymer, wherein the leaflet is impermeable, and wherein the leaflet has a tensile strength in at least two orthogonal directions greater than about 35 MPa.   
     
     
         2 . The prosthetic valve of  claim 1 , comprising only one coherent single layer. 
     
     
         3 . The prosthetic valve of  claim 2 , wherein the leaflet has a break force of greater than about 1 N/mm. 
     
     
         4 . The prosthetic valve of  claim 2 , wherein the leaflet has a break force of greater than about 2 N/mm. 
     
     
         5 . The prosthetic valve of  claim 2 , wherein the leaflet has a break force of greater than about 3 N/mm. 
     
     
         6 . The prosthetic valve of  claim 1 , wherein the leaflet has a thickness of less than about 1 micron. 
     
     
         7 . The prosthetic valve of  claim 1 , wherein the leaflet comprises elastomer or elastomeric material by weight in a range from about 35% to about 90%. 
     
     
         8 . The prosthetic valve of  claim 1 , wherein the elastomer or elastomeric material is selected from the group consisting of silicones, fluoroelastomers, urethanes, and mixtures thereof. 
     
     
         9 . The prosthetic valve of  claim 1 , wherein the elastomer or elastomeric material is a TFE/PMVE copolymer. 
     
     
         10 . The prosthetic valve of  claim 9 , wherein the TFE/PMVE copolymer comprises from about 40 to about 80 weight percent perfluoromethyl vinyl ether and complementally from about 60 to about 20 weight percent tetrafluoroethylene. 
     
     
         11 . A prosthetic valve comprising:
 a frame; and   a leaflet coupled to the frame and the leaflet including at least one coherent single layer and an elastomer or elastomeric material, the at least one coherent single layer having pores and is a synthetic polymer, the elastomer or elastomeric material being present in the pores such that the at least one coherent single layer is impermeable, wherein the at least one coherent single layer is expanded fluoropolymer, wherein the elastomer or elastomeric material is a TFE/PMVE copolymer, and wherein the prosthetic valve is operable to be a prosthetic heart valve.   
     
     
         12 . The prosthetic valve of  claim 11 , wherein the elastomer or elastomeric material is a copolymer of TFE/PMVE. 
     
     
         13 . The prosthetic valve of  claim 12 , wherein the TFE/PMVE copolymer comprises from about 40 to about 80 weight percent perfluoromethyl vinyl ether and complementally from about 60 to about 20 weight percent tetrafluoroethylene. 
     
     
         14 . A prosthetic valve comprising:
 a frame; and   a leaflet coupled to the frame, the leaflet comprising at least one coherent single layer and an elastomer or elastomeric material, wherein the at least one coherent single layer is a synthetic polymer, wherein the leaflet is impermeable, wherein the leaflet has a compression set of less than 10%.   
     
     
         15 . The prosthetic valve of  claim 14 , wherein the leaflet compression set is less than 5%. 
     
     
         16 . The prosthetic valve of  claim 14 , wherein the leaflet compression set is less than 1%. 
     
     
         17 . The prosthetic valve of  claim 14 , wherein the elastomer or elastomeric material is a TFE/PMVE copolymer. 
     
     
         18 . The prosthetic valve of  claim 17 , wherein the TFE/PMVE copolymer comprises from about 40 to about 80 weight percent perfluoromethyl vinyl ether and complementally from about 60 to about 20 weight percent tetrafluoroethylene.